| 商品名称 | Pylclari |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Prostatic Neoplasms |
| 通用名/非专利名称 | piflufolastat (18F) |
| 活性成分 | Piflufolastat (18F) |
| 产品号 | EMEA/H/C/005520 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | V09 |
| 是否额外监管 | yes |
| 是否仿制药 | no |
| 是否生物类似药 | no |
| 是否附条件批准 | no |
| 是否特殊情形 | no |
| 是否加速审评 | no |
| 是否罕用药 | no |
| 批准上市日期 | 2023/07/24 |
| 上市许可持有人/公司名称 | Curium Pet France |
| 人用药物治疗分组 | Diagnostic radiopharmaceuticals |
| 审评意见发布日期 | 2023/05/25 |
| 决定日期 | 2023/11/27 |
| 修订号 | 1 |
| 适应症 | This medicinal product is for diagnostic use only.Pylclari is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings:Primary staging of patients with high-risk PCa prior to initial curative therapy,To localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent.Pylclari is indicated for use with positron emission tomography (PET). |
| 首次发布日期 | 2023/07/28 |
| 修订日期 | 2023/11/30 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/pylclari-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/pylclari |